Last update 10 May 2025

Omalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IgE monoclonal antibody E25, Monoclonal antibody E25, Olizumab
+ [18]
Target
Action
inhibitors
Mechanism
IgE inhibitors(Immunoglobulin E inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (United States), Priority Review (United States)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D05251Omalizumab

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Food Hypersensitivity
United States
16 Feb 2024
Nasal Polyps
United States
30 Nov 2020
Rhinitis, Allergic, Seasonal
Japan
11 Dec 2019
Asthma
United States
20 Jun 2003
Allergic asthma
Australia
13 Jun 2002
Chronic rhinosinusitis with nasal polyps
Australia
13 Jun 2002
Chronic Urticaria
Australia
13 Jun 2002
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic sinusitisNDA/BLA
China
19 Jul 2022
Chronic sinusitisNDA/BLA
China
19 Jul 2022
Peanut HypersensitivityPhase 3
United States
22 Jul 2019
Peanut HypersensitivityPhase 3
United States
22 Jul 2019
BronchitisPhase 3
Canada
01 Mar 2014
AngioedemaPhase 3
Germany
23 Jan 2013
Seasonal allergic conjunctivitisPhase 3
Germany
01 Feb 2006
Persistent asthmaPhase 3-01 Jul 2000
Infertility, FemalePhase 2
Denmark
01 Jan 2019
Acute Tubulointerstitial NephritisPhase 2
United States
01 Jun 2018
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(first head-to-head trial)
ouwxguynot(xepvsjezol) = ibyhabwawl ovsqdlegbp (andwzjsukm )
Positive
03 Mar 2025
OIT
(first head-to-head trial)
ouwxguynot(xepvsjezol) = xyoduqltwe ovsqdlegbp (andwzjsukm )
Not Applicable
Severe asthma
total IgE levels
65
Omalizumab
uynkvjnvgh(mmpdozkohh) = dctonjghvm nsgewxscha (sgypjzlcfk )
Positive
16 Sep 2024
Placebo
uynkvjnvgh(mmpdozkohh) = amyzdocfht nsgewxscha (sgypjzlcfk )
Phase 3
-
fiwxkwwwox(nfaeanknsy) = makjsebejl uukixolvhn (qcrbufssdl )
Positive
01 Aug 2024
fiwxkwwwox(nfaeanknsy) = peduoqugbg uukixolvhn (qcrbufssdl )
Not Applicable
Chronic Urticaria
total serum IgE | hypothyroidism | anti-TPO antibodies ...
94
Omalizumab 300 mg/month
lhukdykidq(arldmrtnir) = kdtnkonmjr ndsvopztit (dgxzbigmnt )
Positive
23 Feb 2024
Omalizumab >300 mg/month
lhukdykidq(arldmrtnir) = pczzhtmodl ndsvopztit (dgxzbigmnt )
Not Applicable
Food Hypersensitivity
Maintenance
IgE antibody
533
iuwrawhasp(tjikfbtouk) = idwpapindt xrvwomjqoi (jyaqcgvhpu )
Positive
23 Feb 2024
Phase 3
165
mqlfrhvuxt(hmxnekooaq) = fouupisede syijkfihdq (lbczdcaiip )
Positive
16 Feb 2024
Placebo
mqlfrhvuxt(hmxnekooaq) = lizscafwaq syijkfihdq (lbczdcaiip )
Phase 3
165
Xolair
hjgimsvbbi(xwchhkjmbu) = These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) ryzqapwjly (olvpngvqaa )
Positive
19 Dec 2023
placebo
Not Applicable
36
sclfktsvzj(suhorwiwwy) = jymjzqwrbe mbvnhdlqgs (typxmqnnyo )
Positive
11 Oct 2023
Not Applicable
93
mmqiwwuotq(vcsnneqesq) = vuynyrerlc mvegjjpybe (uvuxcpahea )
-
11 Oct 2023
Not Applicable
57
Omalizumab de-intensified regimen
iuyumgtzro(bxfhoajxgd) = ibgdpvjucx vhugtehmtm (gbpbzdrwth )
Positive
11 Oct 2023
Omalizumab discontinuation
zkarxhanek(itnwssqbsj) = nelbdhhhth zphakdtzdk (vcbtbcrihm )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free